Catalog Number

-

Brand Name

Regard

Version/Model Number

A3ISRGSTXXL-REG

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192290,K192290

Product Code

FYA

Product Code Name

Gown, Surgical

Public Device Record Key

8feeb1eb-ed84-436f-a502-f147d1fff16b

Public Version Date

April 07, 2021

Public Version Number

2

DI Record Publish Date

May 26, 2020

Package DI Number

10326053117760

Quantity per Package

24

Contains DI Package

00326053117763

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-